The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses

Obesity Clinical Trial

Official title:

The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses and 24 Hour Macronutrient Consumption - A Double Blind, Cross-over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683929
• Other study ID #: MeirMc017112CTIL
• Status: Completed
• Phase: N/A
• First received: September 10, 2012
• Last updated: April 13, 2015
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2014
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to determine the hormonal/metabolic reponse to ingestion of sugar compared to consuming artificial sweetened drink, and to evalute macronutrient consumption 24 hours post ingestion of the drinks.

We hypothesize that artificially sweetened (AS) consumption will lead to a relatively similar hormonal/metabolic responses as glucose consumption and therefore to secondary rise of caloric intake.

Description:

During the last two decades, the prevalence of overweight and obesity doubled. at the same time, individuals have increasingly turned to artificially sweetened (AS) foods and beverages in an attempt to lose weight, or control it.

several studies have found that there may be a connection between artificially sweetened food and beverages consumption and paradoxical weight gain and increased incidence of metabolic syndrome. the causal relationship between AS use and weight gain haven't been proven yet.

The participants will be invited to 2 meetings in which they will consume, in a randomized double blind way:

1. A beverage containing 75 gram glucose

2. A beverage containing 0.42 gram artificially sweetener (Aspartame, similar sweetness level)

During each meeting, the participants will drink the sweetened drink followed by blood work, as done in oral glucose challenge or tolerance test (OGTT / GTT).

Also, they will record their macronutrient\caloric consumption during the 24 hour following the test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 35 Years

Eligibility

Inclusion Criteria:

• Adults, healthy, men and women, ages 25-35 years, without any chronic illnesses.

Exclusion Criteria:

• Family history of diabetes or overweight with BMI> 27

• Use of drugs who can influence the glucose metabolism (exp: glucocorticoids).

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• glucose
The participants will report to the lab after an overnight fast. Their BMI, HR and BP will be measured. An IV catheter will be inserted into the brachial vein and the participants will rest for half an hour. Participants will drink A beverage containing 75 gram glucose (oral glucose tolerance test (OGTT / GTT) All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH and other related hormones- before consuming the drink (time 0), and at 30, 60, 120, 180 minutes after. The participants HR & BP will be monitored throughout the examination + 1 hour after. In addition, the participants will be asked to complete a- "24 hr food questionnaire".
• sweetner
The participants will report to the lab after an overnight fast. Their BMI, HR and BP will be measured. An IV catheter will be inserted into the brachial vein and the participants will rest for half an hour. Participants will drink A beverage containing artificial sweetened drink. All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH and other related hormones- before consuming the drink (time 0), and at 30, 60, 120, 180 minutes after. The participants HR & BP will be monitored throughout the examination + 1 hour after. In addition, the participants will be asked to complete a- "24 hr food questionnaire".

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba
Israel	Meir Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hormonal response	All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH- and other related hormones before consuming the drink (time 0), and 30, 60, 120, 180 minutes after.; The participants will be under medical supervision throughout the examination, including HR & BP montoring, and until 1 hour after	3 hours	No
Secondary	food questionnaire	The participants will be receiving a- "24 hr food questionnaire" which they will fill during the day after consuming the drink followed by an interview in order to get the maximal information.	24 hours	No